PUGRITEX Capsules Gastro-Resistant 10 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OMEPRAZOLE

Available from:

Laboratorios Davur S.L.U.

Dosage:

10 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Authorization date:

2010-10-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pugritex 10 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of Omeprazole.
Excipients:
Each 10mg capsule contains 44.16 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard.
Opaque red cap and opaque orange body, containing white to beige granules.
Size 3 capsule marked with O10.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pugritex capsules are indicated for:
Adults
Treatment of duodenal ulcers
Prevention of relapse of duodenal ulcers
Treatment of gastric ulcers
Prevention of relapse of gastric ulcers
In combination with appropriate antibiotics, _Helicobacter pylori (H.pylori) _eradication in peptic ulcer disease
Treatment of NSAID-associated gastric and duodenal ulcers
Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
Treatment of reflux esophagitis
Long-term management of patients with healed reflux esophagitis
Treatment of symptomatic gastro-esophageal reflux disease
Treatment of Zollinger-Ellison syndrome
Paediatric use
_Children over 1 year of age and_
_10 kg_
Treatment of reflux esophagitis
Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/01/2012_
_CRN 2102083_
_page number: 1_
_Children and adolescents over 4 years of age_
In combination with antibiotics in treatment of duodenal ulcer caused by _H. pylori_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in adults
_Treatment of duodenal ulcers_
The recommended dose in patients with an active duodenal ulcer is Pugritex 20 mg once daily. In most patient